MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS SMARTSITE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20127E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite extension set was occluded.The following information was received by the initial reporter with the following verbatim: we have had several reports of lipids clogging the filter then alarming high pressure.Nursing is able to flush.9 through the system but lipids stop running.In one event the lipids actually solidified in the tubing, and they were unable to flush.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported by customer that they had several reports of lipids clogging the filter then alarming high pressure.Two samples of material number 20127e were received for quality investigation.One sample was unused and still in the original packaging and the second sample was opened and was filled with white fluid, possibly lipids.The unopened and unused sample was tested for any flow issues by connecting it to 10 ml bd syringe filled with water.This test was to check if fluid would be allowed through the sample.Fluid flowed through the sample without any issue.The second sample was then test in the same manner.A flow issue was identified with the second sample that looked to have been used with a thick white fluid.The sample was then cleared of the white fluid, and making sure that the filter component was free of the while fluid within the filter body.After clearing the fluid from the filter, the extension set appeared to work as expected, and without any flow issues.The customer complaint of flow issue - fluid blockage was replicated during testing the submitted sample, however, after clearing the medication used from the filter, fluid flow was established, and therefore the product failure could not be confirmed.The root cause of the issue could not be determined.Bd is aware of this issue and is working on improving the filter.A device history record review for model 20127e, lot number 24069281 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12jun2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
Material#: 20127e, batch number#: 24069281.It was reported by customer that they had several reports of lipids clogging the filter then alarming high pressure.Nursing is able to flush.9 through the system but lipids stop running.In one event the lipids actually solidified in the tubing, and they were unable to flush.Verbatim #: rcc received a complaint via phone.We have had several reports of lipids clogging the filter then alarming high pressure.Nursing is able to flush.9 through the system but lipids stop running.In one event the lipids actually solidified in the tubing, and they were unable to flush.Item #: 20127e, lot #: 24069281.

• Brand Name: BD ALARIS SMARTSITE EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20351609
• Report Number: 9616066-2024-01418
• Device Sequence Number: 8062458
• Product Code: FPA
• UDI-Device Identifier: 07613203019248
• UDI-Public: (01)07613203019248(11)240612(17)270612(10)24069281
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 20127E
• Device Lot Number: 24069281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown